Network of European Reference Centers in Neurosonology (ERN Sono)

During the meeting of the EAN Scientific Panel of Neurosonology in Copenhagen 2016, it was decided to establish a Network of European Reference Centers in Neurosonology (ERNSono). This network is designed as a reference network, which works in close cooperation with the European Society of Neurosonology and Cerebral Hemodynamics [ESNCH]). The Executive Committee of the ESNCH has decided during the annual meeting in Berlin 2017 to joiand to support this initiative.

Objective
Neurosonology is an outstanding diagnostic instrument in the hand of clinical neurologists with unique selling points such as specific imaging technology, high spatial resolution, online observation, noninvasiveness as well as broad and easy availability in the clinical routine all over Europe. Beside “traditional” vascular neurology, currently new fields of application such as muscle and nerve imaging, orbital ultrasound and online monitoring techniques in intensive care are booming. There is a definite need for a well-structured clinical network to seek for further technical progress, to offer a profound education and training program, to test the usefulness of ultrasound in new fields, to implement it in clinical trials and to foster the application of sonography in daily practice. The EAN as the leading neurological society in Europe in concert with the ESNCH as the leading society in the field of neurosonology offers now the unique opportunity to launch the ERNSono.

B. Personnel facilities1. The Chief of the neurosonology laboratory has to be a neurologist sonographer with certified national or international experience in neurosonology*.
The Chief must have examined more than 3000 patients confirmed by the head of the clinical department or institution.
2. Two sonographers/medical staff with national or international certified experience in neurosonology. They must have examined more than 2000 patients confirmed by the head of the clinical department.
3. Membership in European neurosonological organizations (EAN Neurosonology Panel and either ESNCH or Neurosonology Research Group of the WFN).

D. Scientific Activities1. At least 5 publications, of which 2 in the last five years, as first or senior author with neurosonology topics in journals with IF > 1.0.
2. Publications must contain original data.

F. Teaching activities1. Organization or active participation as faculty in atleast 3 international neurosonological courses during the last 10 years under the auspices of national or international societies.
2. Compliance and support of the teaching and certification concept of the EAN/ESNCH/NSRG.

G. The Neurosonology Laboratory belongs to the clinical department of Neurology or Institution, which can provide instructive patients for teaching courses and recruit cases for research trials.

H. Adherence to the ERN Standards for Neurosonology Laboratories

I. Re-accreditation every 5 yrs.

J. Letter of recommendation from SP member

Perspective
The ERNSono may serve as a perfect starting point to establish a functional network connecting health care providers and centers of expertise of highly specialized healthcare, for the purpose of improving access to diagnosis and treatment, and offering high-quality healthcare for patients.
The ERN will promote expertise and support health care providers in order to bring local, regional and national provision of healthcare closer to the patients.

It is the aim of ERNSono to include as many qualified centers in Europe as possible into the network.

* ESNCH International Certification for Neurosonology or official certification granted by the national neurological societies (or their sections).

Standard Operating Procedure

Document #

ERNSono 1.1

Title:

Network of European Reference Centers in Neurosonology

Print Date:

12 September 2017

Revision #

1.1

Prepared By:

David Skoloudik, Branko Malojcic, Elsa Azevedo

Date Prepared:

01 September 2017

Effective Date:

01 September 2017

Reviewed By:

Manfred Kaps, László Csiba, Claudio Baracchini

Date Reviewed:

13 September 2017

Standard:

Standard ERNSono

Approved By:

Manfred Kaps – EAN SP Neurosonology, Claudio Baracchini - ESNCH

Date Approved:

13 September 2017

Definition The EAN Scientific Panel of Neurosonology decided to establish a Network of European Reference Centers in Neurosonology (ERNSono) in 2016. This network is designed as a reference network, which works in close cooperation with the European Society of Neurosonology and Cerebral Hemodynamics [ESNCH]). The Executive Committee of the ESNCH has decided during the annual meeting in Berlin 2017 to join and to support this initiative.

Purpose Neurosonology is an outstanding diagnostic instrument in the hand of clinical neurologists with unique selling points such as specific imaging technology, high spatial resolution, online observation, noninvasiveness as well as broad and easy availability in the clinical routine all over Europe. Beside “traditional” vascular neurology, currently new fields of application such as muscle and nerve imaging, orbital ultrasound and online monitoring techniques in intensive care are booming.
There is a definite need for a well-structured clinical network to seek for further technical progress, to offer a profound education and training program, to test the usefulness of ultrasound in new fields, to implement it in clinical trials and to foster the application of sonography in daily practice.
The EAN as the leading neurological society in Europe in concert with the ESNCH as the leading society in the field of neurosonology offer now the unique opportunity to launch the ERNSono.

Certification of the European Reference Centers in Neurosonology: Certification of the European Reference Centers in Neurosonology (ERNSono Certification) is a protocol granted by the European Academy of Neurology (EAN) in cooperation with the European Society of Neurosonology and Cerebral Hemodynamics (ESNCH) according to which the centers that meet criteria of the highest quality performance in neurosonology techniques by an experienced team, a routine link to clinical network, and conditions to offer good education and training programs will become members of the Network of European Reference Centers in Neurosonology (ERNSono).
Granting Authority: Steering Committee of the European Academy of Neurology Scientific Panel (SP) Neurosonology and the European Society of Neurosonology and Cerebral Hemodynamics Executive Committee (EAN / ESNCH Steering Committee). EAN / ESNCH Steering Committee: The Committee analyses if the application meets all the criteria of the ERNSono, and is constituted by 3 members, 2 from the EAN SP Neurosonology and 1 from the ESNCH Executive Committee. Steering Committee members may conduct ad hoc visits to randomly selected ERNSono Centers or candidate centers in order to supervise the working protocols or fulfillment of requested criteria of excellence.

Supervisory Authority: Chair of the Management Group of the EAN Scientific Panel Neurosonology and the President of the European Society of Neurosonology and Cerebral Hemodynamics are supervising the EAN / ESNCH Steering Committee process of the ERNSono certification. Both authorities have a possibility to exercise the power of veto for each EAN / ESNCH Steering Committee decision.
Duration of mandate for the members of the EAN / ESNCH Steering Committee: Four years

Election of the members of the EAN / ESNCH Steering Committee: Two members of the Committee are elected during the EAN Congress SP Neurosonology meeting, being elected alternately every 2 years in the even year. The candidate is elected by a simple majority of the members of the SP of Neurosonology. One member of the committee is elected during the ESNCH Meeting every 4 years in the odd year. The candidate is elected by a simple majority of the members of the ESNCH Executive Committee
Revocation of a member of the EAN / ESNCH Steering Committee: Revocation is possible at member´s own request, at the request of any member of the EAN Scientific Panel of Neurosonology or of the ESNCH Executive Committee. The revocation has to be approved by an absolute majority of the members of the EAN SP Neurosonology or the ESNCH Executive Committee, resp.
Criteria for the ERNSono and Application Form: The Management Group of EAN SP created the Criteria for the ERNSono Certification (see Criteria for the ERNSono Certification document) in cooperation with ESNCH Executive Committee. The Criteria for the ERNSono Certification has been approved by EAN and ESNCH. The EAN / ESNCH Steering Committee ensures the availability of the Application Form on the EAN and ESNCH websites and during the EAN and ESNCH congresses.
Application Form changes: The changes in the Criteria for the ERNSono Certification can be proposed by any member of the EAN Scientific Panel of Neurosonology and the Executive Committee of the ESNCH and approved by simple majority of the EAN SP Neurosonology and simple majority of Executive Committee of ESNCH. After that the final approval will be done by EAN.
Application for the ERNSono Certificate: The application is valid only when all the required data in the Application Form are filled in. A valid Application Form with other necessary documents should be submitted by e-mail to: EANernsono@gmail.com (Subject: ERNsono Application Form). Confirmation of receipt will be send back within 30 consecutive days.
Evaluation of the Application: The EAN / ESNCH Steering Committee will assess whether the Applicant center has met all the criteria or not within the next 30 consecutive days.
Applications Approval: When passing the criteria, the EAN / ESNCH Steering Committee will send the Application to the Chairperson of the Management Group of EAN SP Neurosonology and to the President of the ESNCH Executive Committee to approve the certification. They should approve the Certification within 20 consecutive days.

Certificate: After approval of the certification by both Chairpersons, the EAN / ESNCH Steering Committee will send the Certificate to the applicant within 20 consecutive days.
Certificate validity: 5 years
Re-certification: The Applicant will send the Application Form to the EAN / ESNCH Steering Committee at the latest on the expiration date of the Certification 5-year validity period. The EAN / ESNCH Steering Committee will assess whether the applicant has still met all the criteria within 30 consecutive days. When passing the criteria, the EAN / ESNCH Steering Committee will send the Certification to the Applicant and inform the Chairpersons of SP Neurosonology and ESNCH Executive Committee.
Cancellation of Certification: In the case of false data in the Application Form, Certification should not be granted to the Applicant for the next 3 years. If the filled false data in the Application Form will be found after approval of the Certification the EAN / ESNCH Steering Committee is entitled to withdraw the Certification without delay.
Appeal against a decision of the EAN / ESNCH Steering Committee: Appeal against a decision of the EAN / ESNCH Steering Committee not to grant or to withdraw the Certification may be send to the Chairman of the EAN SP Neurosonology within 20 consecutive days of delivery of the decision. The Chairperson may re-open the EAN / ESNCH Steering Committee request within 30 consecutive days if the appeal is justified. Upon unsuccessful application, the applicant may file a new application after 12 months from the decision. In the case of false data in the Application Form, the applicant may send a new Application Form after at least 36 months after receiving the decision.

Standards for ERN Laboratories

1. Personnel and responsibilities

1.1.Responsible physician: A physician experienced in cerebrovascular disease has to be responsible for all diagnostic services provided by the neurosonology laboratory, both concerning the appropriateness and technical aspects of testing as well as the practical performance, documentation and correct interpretation.
1.1.1. Qualification of the responsible physician:
The physician is specifically qualified according to the ERN criteria.

1.1.2 Continuous education: The responsible physician has to maintain his level of knowledge in the field of neurovascular ultrasound by participating to CME courses concerning vascular ultrasound or equivalent training courses.

1.2. The medical staff working in the neurovascular lab under the supervision of the responsible physician takes part in the practical examination, documentation and reporting but needs supervision by the responsible physician unless they have the same qualification.

1.3.The technical staff: The technical staff is not an essential requirement but in general it improves quality of service, as it can provide secretary work or take part in the examination. If it takes part in the examination of patients, the physician in charge is responsible for the correct application and reporting of the test. The technical staff must be certified by an established training program (nurse, medical or radiological assistant) or by a training of at least 12 month full-time in a certified neurosonology laboratory. The physician in charge is also responsible for the training of technical staff as well as for an adequate continuous education.

2. Standards of examination

2.1. The extracranial examination (CW-Doppler-sonography, (CW) Color Duplex-sonography) includes the following arteries always on both sides:
common carotid artery (CCA)
external carotid artery (ECA)
internal carotid artery (ICA)
vertebral artery (VA)
subclavian artery (SC)
branches of the ophthalmic artery (if appropriate)
venous vessels (if appropriate)
The ICA has to be examined close to the origin and followed distally as far as possible. The vertebral artery has to be examined at least in two segments, always as close as possible at the origin and in the V2 or V3 segment.

3.1. Format: Reports have to be given in a standard format. Identification of the technologist or physician performing the vascular examination must appear on the record. The final results and related report has to be signed by the responsible physician or another member of the medical staff with similar reporting experience as described for the responsible physician.

3.2. Content: The contents of the report must include: a. The clinical indication leading to the performance of the examinations b. A detailed description of the techniques used and the result of the examination of each examined artery or vein. c. The final conclusion (interpretation of results)

3.3. Documentation: Documentation in the report has to be provided for each examined arterial segment. If it is not possible to examine a specific segment, the most probable reason for that has to be indicated. In case of abnormal findings, results have to be quantified: blood flow velocity, the percentage of stenosis, etc. Pathologic findings should be visualized and documented in two planes if possible.